Neocartilage Implant to Treat Cartilage Lesions of the Knee

Stopped early · Phase 3

Conditions studied: Articular Cartilage Disorder, Degeneration; Articular Cartilage, Chronic Cartilage Injury, Acute Cartilage Injury, Defect of Articular Cartilage

In brief

ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to microfracture treatment.

Key facts

Study ID

NCT01400607

Run by

ISTO Technologies, Inc.

People needed

14

Starts

2011-07-01

Expected to finish

2020-09-01

Last updated by the study team

2017-08-31

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Generally, the following inclusion criteria must be met, however, this is not a complete list.
• Male or Female between the ages of 18 and 60
• (1) or (2) articular cartilage lesions of the distal femur ranging in no more than 5 cm2 each
• Ipsilateral knee compartment has intact menisci (or meniscectomized remnant with > 5mm wide rim) and stable ligaments in the affected knee
• 3 months out from initiation of conservative non-surgical management (e.g.hyaluronic acid injection, activity modification) or previous minimal surgical intervention (e.g., arthroscopic lavage, debridement) or 12 months out from marrow stimulation for this condition

You may not qualify if…

• Generally, if a potential participant meets any of the following criterions, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.
• Osteoarthritis
• Rheumatoid arthritis
• History of septic or reactive arthritis
• Gout or a history of gout or pseudo-gout in the affected knee
• Osteochondritis dissecans or osteochondral lesions of the knee with bone loss > 6mm deep
• Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface)
• Associated damage to the underlying subchondral bone requiring an osteochondral graft
• Is pregnant or breast-feeding
• Has a BMI > 35 (kg/m2)
• Has prior total meniscectomy of either knee
• Has received, within the past three months, intra-articular hyaluronic acid therapy, or steroid therapy
• Has more than two clinically relevant chondral lesion(s) on the index knee

Where it is running

• Kerlan Jobe Orthopaedic Clinic — Los Angeles, California, United States
• Santa Monica Orthopaedic & Sports Medicine Group — Santa Monica, California, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Hospital for Special Surgery -Sports Medicine and Shoulder Service — New York, New York, United States
• Insall Scott Kelly Institute for Orthopaedics & Sports Medicine — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University Sports Medicine Center — Columbus, Ohio, United States
• The Hawkins Foundation — Greenville, South Carolina, United States
• The Methodist Hospital Research Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.